Lower-dose ATG plus mini post‑transplant cyclophosphamide to prevent GVHD after haploidentical stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional protocol testing a reduced dose of anti‑thymocyte globulin (ATG) together with a mini course of post‑transplant cyclophosphamide (PTCy) as graft‑versus‑host disease (GVHD) prophylaxis after haploidentical hematopoietic stem cell transplantation. Eligible patients are 12–65 years old undergoing their first haploidentical transplant for acute leukemia in remission or myelodysplastic syndrome, excluding maternal and collateral donors. The regimen aims to balance immune suppression to lower GVHD risk while limiting infection and relapse, with close monitoring of transplant‑related mortality, infections, GVHD incidence, and disease control. The single‑center study is conducted at Peking University People's Hospital with planned follow‑up to track safety and efficacy outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with AL - CR and/or myelodysplastic syndromes undergoing allogeneic hematopoietic stem cell transplantation for the first time;
2. No gender limit, aged 12 - 65 years;
3. Planned haploidentical donor transplantation, excluding transplantation from maternal and collateral donors;
4. Eastern Cooperative Oncology Group (ECOG) performance status score≤3 points;
5. Baseline organ function tests meet the following criteria:

(1) Left ventricular ejection fraction (LVEF) \> 55%; (2) Serum creatinine ≤ 1.5 × upper limit of normal (ULN).

Exclusion Criteria:

1. Patients with severe dysfunction of brain, heart, kidney or liver;
2. Those in refractory malignant status;
3. Patients with other malignancies requiring treatment;
4. Presence of uncontrolled severe active infection clinically;
5. Expected survival period of less than 3 months;
6. History of severe allergic reactions;
7. Pregnant or breastfeeding women; (8)Presence of any condition deemed by the investigator as unsuitable for study enrollment.

Where it's running

• Peking University People'S Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yu Wang, M.D.
• Email: ywyw3172@sina.com
• Phone: 86-010-8832-6000

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• Preventing GVHD in children and young adults with blood cancers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.